21St Century Cures Act

21ST CENTURY IssueBrief March 2018 CURES ACT

Discovery, Development and Delivery: The 21st Century Cures Act

romising big money for cancer and brain research, faster approval for new drugs and funding for opioid abuse treatment, the 21st “The 21st Century Cures Act is P Century Cures Act was legislation everyone could support. President Barack Obama signed the $6.3 billion law in December 2016—his final a sweeping law, passed with month in office. He then handed the official signing pen to Vice President nearly unanimous bipartisan Joe Biden, whose late son’s death from brain cancer inspired widespread support for the measure. support. It’s designed to accelerate the discovery, “The 21st Century Cures Act is a sweeping law, passed with nearly unanimous bipartisan support,” says MaryBeth Kurland, CAE, CCMC’s development and delivery chief executive officer. “It’s designed to accelerate the discovery, of cures and treatments for development and delivery of cures and treatments for all Americans.” all Americans.” Those three pillars—discovery, development and delivery—provide a high-level framework for examining the significant changes the 21st — MARYBETH KURLAND, CAE Century Cures Act (the Cures Act) will make in how the nation develops CEO, COMMISSION FOR CASE treatments and uses health information technology to expand the MANAGER CERTIFICATION “cures” landscape. Parkinson’s disease, from neurological disorders and cancer, for “This funding will spur new cures and treatments, and that’s critical which we have no cure,” she says. for case managers. Staying aware of some of the emerging break- “It takes investment and focus in the NIH and other agencies to throughs in these areas is going to be really important in your role.” make that happen.”

— JANET MARCHIBRODA, DIRECTOR, HEALTH INNOVATION EXECUTIVE DIRECTOR, CEO COUNCIL ON HEALTH AND INNOVATION Although the NIH funding must be BIPARTISAN POLICY CENTER approved by Congress for each budget year, support for research in the Cures Act has not waned since its passage, Marchibroda notes. “As you look at the budget “The 21st Century Cures Act is a Improve data sharing among activity, there’s continued interest big package,” says Janet Marchi- researchers; in supporting the NIH. That’s impor- broda, director of the Bipartisan tant, because one study showed Policy Center’s Health Innovation Strengthen privacy protections that more than 60 percent of the Initiative and executive director for research volunteers; and most important drugs on the of its CEO Council on Health and market resulted from NIH-funded Innovation. “A lot of the support Enhance research that includes research grants,” she says. for the Cures Act related to the diverse populations.1 almost three years of work leading “This funding will spur new cures up to its passage, including town Jump-starting research and devel- and treatments, and that’s critical halls and public meetings, opment of new treatments is at for case managers. Staying aware with collaboration from both the core of the Cures Act. “It takes of some of the emerging break- democrats and republicans.” more than 10 years and more than throughs in these areas is going to $2 billion, on average, to bring new be really important in your role.” treatments to patients in the U.S.,” Center stage: Discovery Marchibroda says. While many Research to find cures By far the largest outlays in the other countries have been invest- Cures Act are for new research ing in research and development, for "All of Us" funding for the National Institutes the level of development—and NIH’s Precision Medicine Initiative of Health. Over the next decade, efficiency—in the U.S. fell behind. garners $1.45 billion in total fund- the NIH will spend $4.8 billion on “We have about 10,000 known ing. Referred to as the “All of Us” four initiatives: precision medicine, diseases, but only treatments for initiative,2 it’s laying the foundation brain research, the “Cancer Moon- about 500,” she says. to accelerate health research shot” and adult stem cell research. and enable individualized preven- From 20,000 feet, the Cures Act tion and treatment findings. The But the Cures Act also streamlines is a means to clear barriers to initiative builds an entirely new how that research is carried out. medical advancement, while data set, seeking information from It includes measures to: opening the door for health infor- a million individuals—including mation and data exchange to health claims information plus Cut through administrative red better support the work. “Many, data on the biological, behavioral tape that can delay clinical many millions of Americans are and environmental factors that trials; suffering from Alzheimer’s or affect health.

Allow researchers to collabo- 1 The 21st Century Cures Act. National Institutes of Health. https://www.nih.gov/research- 2 For more on the All of Us initiative, see https:// rate with one another more; training/medical-research-initiatives/cures allofus.nih.gov.

2 All of Us is intentionally gathering understand reimbursement options Parkinson’s disease also elude data from a diverse population. available to patients who wish to successful treatments. Once gathered, the data will undergo genetic screening and be available to researchers in a pursue precision medicine options, The Cures Act provides more than de-identified format. The aim is and then coach patients to help $1.5 billion in funding for the Brain to equip researchers to produce them pursue different treatments.” Research through Advancing more targeted, individualized Innovative Neurotechnologies treatments. (BRAIN) Initiative. Its goal is to accelerate development of “Traditionally, research has looked "Case managers will need to technology that helps researchers at the health of populations, not understand reimbursement better understand how the brain individuals,” Marchibroda says. works, which will, in turn, acceler- “Clinical trials tend to use a one- options available to patients ate research to find cures for neu- size-fits-all approach. The popula- who wish to undergo genetic rological diseases. In 2017, the NIH tions don’t include patients with invested the first $260 million to co-morbidities. They tend not to be screening and pursue fund research that will map whole the older or the younger patients. precision medicine options, brains in action, offer the ability to Often there are not as many identify thousands of brain cells at women or minorities represented. and then coach patients to once, and produce innovative 4 They don’t reflect the real world. help them pursue different brain scanners. But there is so much that can impact how we as individuals treatments.” The Cancer Moonshot is another react to a medical product—our major area of NIH funding under genetics, our lifestyle, the foods we — JANET MARCHIBRODA the Cures Act. Cancer research to eat, how much we exercise, and DIRECTOR, HEALTH INNOVATION develop vaccines, improve diag- EXECUTIVE DIRECTOR, CEO COUNCIL the environments in which we live.” nostic tests and develop new treat- ON HEALTH AND INNOVATION ments is already going forward. BIPARTISAN POLICY CENTER Personalized data can be used “This research has the potential to to better fit treatments to the per- transform the field,” Marchibroda son, she notes. Over the past year, says. In 2017, NIH awarded grants the All of Us initiative has actively Tackling the century’s to 142 Cancer Moonshot research engaged health providers, big health problems projects—spending $300 million of community health centers and the $1.8 billion total funded the Veterans Health Administration In 2017 alone, about 1.7 million through the Cures Act.5 to launch the data gathering new cancer cases were diag- effort. The national rollout of the nosed in the U.S. and more than A glide path for drug All of Us program is expected to 600,000 Americans died from the begin in the next few months, disease.3 Research in Alzheimer’s development Marchibroda says. disease—the nation’s sixth The Food and Drug Administration leading cause of death—has is responsible for testing new drugs “Precision medicine is now a not succeeded in producing to establish their safety and effec- therapeutic option for Americans,” treatments that even slow its tiveness. The FDA has long had a Marchibroda says. “But in many progress, much less find a cure. cases, reimbursement policies Other neurological disorders like 4 “NIH BRAIN Initiative builds on early advances.” NIH announcement. Oct. 23, 2017. https:// have not caught up with personal- www.nih.gov/news-events/news-releases/ nih-brain-initiative-builds-early-advances ized therapies, and the cost of 3 “Cancer Facts & Figures 2017.” American these therapies is not within reach. Cancer Society, www.cancer.org/research/ 5 Cancer Moonshot. National Cancer Institute. cancer-facts-statistics/all-cancer-facts-fig- https://www.cancer.gov/research/key-initia- Case managers will need to ures/cancer-facts-figures-2017.html tives/moonshot-cancer-initiative

3 process for “expedited review” The Cures Act enhanced the outcomes. Inherently, that takes a of drugs to bring them to market FDA’s review guidelines to further really long time,” Marchibroda says. faster, reserved for drugs that expedite the process and ease the “Biomarkers can be used to select fulfill an unmet clinical need and, requirements for drug approval. It patients for inclusion in clinical trials, therefore, merit faster review. also allows the FDA to use clinical predict or identify safety problems, A study of drugs that have gone biomarkers as surrogates for long- or reveal a pharmaceutical activ- through expedited review be- term outcomes data. Biomarkers ity expected to predict an even- tween 1999 and 2012 found they are objective indications of a tual benefit from a treatment.” provided greater health gains medical condition that can be than those approved through accurately measured. Examples The Cures Act acknowledges the conventional means. In short, the of biomarkers include pulse and value of biomarkers and expands FDA has a solid track record for blood pressure readings and the FDA’s use of appropriate mark- selecting the highest priority drugs results from blood chemistry or ers. “The FDA has the ability to qual- to move through an expedited more complex lab tests.7 ify biomarkers for drug approval, process.6 but it must be transparent about “When you review and approve the processes for doing so. All of a drug, you look at the long-term that is important to manage the risk

6 Chambers, James D., et al. “Drugs Cleared to patients of going down this road, Through The FDA’s Expedited Review Offer so it’s pretty important that case Greater Gains Than Drugs Approved By Con- 7 Strimbu, Kyle, and Jorge A. Tavel. What are ventional Process.” Health Affairs, vol. 36, no. 8, biomarkers? U.S. National Library of Medicine, managers understand this,” Marchi- Jan. 2017, pp. 1408–1415., doi:10.1377/ Nov. 2010. https://www.ncbi.nlm.nih.gov/ broda says. To date, the FDA has hlthaff.2016.1541. pmc/articles/PMC3078627 been working to draft guidance for how biomarkers are reviewed and approved for this purpose.

Mental health measures in the The Cures Act also allows patients to be more directly engaged as 21st Century Cures Act partners in the drug approval process. “In the benefit and risk assessment part of the drug approval he Cures Act includes provisions to strengthen mental health and substance abuse prevention, treatment and recovery programs. The law provides process, many patient groups felt T$1 billion in funding over two years for states to enhance opioid abuse that the patient’s voice wasn’t prevention, treatment and support. Nearly half of that was disbursed via grants really being heard,” Marchibroda to all 50 states in 2017 by the Substance Abuse and Mental Health Services says. The law requires the FDA to Administration.† The funds help states expand the use of prescription drug make public statements regarding monitoring programs, train providers to respond to opioid abuse more effectively, patient experience data that’s and put prevention programs in place. Marchibroda acknowledges progress on submitted as part of any drug this front, but there’s still a long way to go. application. It must establish how patient experience data should “The 21st Century Cures Act didn’t tackle this issue enough to enable that information flow,” she says. “There’s a lot of policy discussion about it, and there are a be gathered and make clear how number of bills out there. I’m confident that with all the focus on opioid abuse, it will be used by the FDA. “Patients we will see progress to enable the sharing of information in an appropriate way, want to be engaged as partners in that still ensures patient privacy.” the drug development process,” Marchibroda says.

† Bresnick, Jennifer. HHS Distributes $458M in 21st Century Cures Opioid Abuse Grants. Health IT Analytics, April 21, 2017. https://healthitanalytics.com/news/hhs-distributes-458m-in-21st-century-cures-opioid-abuse-grants Better use of health data is also now part of the drug approval process. “The federal government has

4 invested almost $40 billion in health generic drugs were approved in information technology and elec- 2017—the highest annual rate in tronic health records, and the vast “Increasing the availability FDA history. majority of our hospitals and physi- of drugs—including generic cian offices are now using them. And that’s good news for patients. Many of us are using all sorts of drugs—will help create personal technology and apps to more competition in the “Increasing the availability of track our health. But none of that drugs—including generic drugs— EHR or patient-generated data marketplace, which can help will help create more competition was considered by the FDA for make treatments more in the marketplace, which can drug approval. The old way of help make treatments more afford- gathering patient experience of affordable and more able and more accessible to care was largely survey-based,” accessible to patients.” patients,” Marchibroda says. Marchibroda says. — JANET MARCHIBRODA Gaining Congressional approval The Cures Act initiates the use of DIRECTOR, HEALTH INNOVATION to use real-world evidence will not real-world evidence about patient EXECUTIVE DIRECTOR, CEO COUNCIL only affect the FDA’s process. It will experience. ”Real-world evidence ON HEALTH AND INNOVATION also support ongoing monitoring that you gain from claims and BIPARTISAN POLICY CENTER of the effectiveness and value billing systems, electronic health of drugs, supporting patient records and patient-generated decision-making. data can help those who approve and develop drugs to really under- understand the impact earlier. “We’re getting ready to see stand how they’re working in the Understanding how a medical amazing things around how wild—in the real world—with a product, a drug or biologic can drugs work—their effectiveness diverse group of patients and in work in smaller populations, and and safety—earlier, based on different practice settings.” earlier in the process, can be help- observational data and real-world ful for patients and payers.” The evidence that will augment Creating more data FDA is developing a framework to randomized control trials. And sources to support cures evaluate the use of real-world evi- that will help us solve a whole dence to support new indications range of issues,” Marchibroda says. The Cures Act doesn’t eliminate or post-approval study require- the use of randomized control tri- ments and is on track to complete Better care delivery: als to test safety and effectiveness its development by December Cure the data-entry blues of drugs. But Marchibroda expects 2018. It is collaborating with private- use of patient-generated data sector data initiatives on demon- The adoption of electronic health and information from EHRs will give stration projects to test the ideas records has placed a wealth of the FDA further insight and “take supporting that framework. patient data in digital form. EHR us to the next level as we look at use is intended to improve access new discoveries.” EHR and patient- For case managers, rapid to individual patient data when generated data can also be used approval of new treatments, providers need it, as well as to assess medical technology and devices and drugs can more enhance quality improvement products for reimbursement. “Real- quickly bring interventions to efforts. EHRs and the ability to track world evidence can tackle both,” patients. The FDA has already treatment and outcomes for popu- she says. “There’s been a lot of increased its drug approval rate; lations also inform private- and discussion around how drug and more than twice as many new publicly-funded provider reim- reimbursement approval can drugs were approved in 2017 bursement initiatives. In the transi- work in parallel, so payers can compared to 2016, and 1,027 tion of health care reimbursement

5 from paying for volume of services how to eliminate some reporting National Coordinator for Health IT to paying for value-based results, requirements—particularly those shows information blocking is a these initiatives have also demanded under the Centers for real problem.11 increased the administrative Medicare & Medicaid Services’ burden on providers to enter EHR Incentives program and The Cures Act puts the burden and track data electronically. its physician reimbursement on EHR developers to certify they programs, as well as reporting don’t participate in information “There have been some unin- associated with the Hospital Value- blocking. They must successfully tended consequences to EHR Based Purchasing program and test real-world use of their technol- adoption,” Marchibroda says. information systems certification. ogy to demonstrate interoperabil- Researchers say primary care phy- ity. They must also attest that they sicians spend nearly two hours on don’t engage in information electronic health record tasks for “Do you have access to the blocking and can face fines of every one hour of patient care.8 up to $1 million for falsifying that Emergency department doctors data you need, across the attestation.12 spend about 43 percent of their care continuum, for the time on data entry, compared to “The law requires that within one 28 percent of time with patients.9 various clinicians that provide year, the Department of Health The burden of reporting quality care to your patients?" and Human Services requires measures is estimated to require health IT developers to go through about 15 hours per week per — JANET MARCHIBRODA certification that they haven’t physician.10 DIRECTOR, HEALTH INNOVATION taken these actions, but that is still EXECUTIVE DIRECTOR, CEO COUNCIL in the process of implementation,” “Quality data submission can be ON HEALTH AND INNOVATION Marchibroda says. In fact, none quite time consuming, so we’re BIPARTISAN POLICY CENTER of the Cures Act’s EHR reporting seeing lower levels of productivity, program steps have been higher operating costs and quite implemented to date. a bit of physician burnout,” Providers are also frustrated that Marchibroda says. competing EHR platforms don’t “The Office of the National Coordi- easily exchange information with nator for Health IT (ONC) told The Cures Act calls for the Depart- one another—often termed Congress they didn’t have the ment of Health and Human interoperability. In the same way resources to carry out this program, Services to reduce this regulatory bank automatic teller machines but we think it’s pretty important,” burden. Four work groups have can access an individual’s bank she says. “The idea is to create been established to determine account from another bank, a more transparency through report- doctor should be able to get ing criteria on measures related to 8 Arndt, Brian G., et al. Tethered to the EHR: needed information from another security, usability and interoperabil- Primary Care Physician Workload Assessment Using EHR Event Log Data and Time-Motion provider’s EHR securely and ity around health information Observations. Annals of Family Medicine, immediately. exchange. Sept/Oct 2017. http://www.annfammed.org/ content/15/5/419.full

9 Hill, Robert G., et al. 4000 Clicks: a productivity One barrier to interoperability is 11 Report to Congress: Report on Health analysis of electronic medical records in a information blocking, an inten- Information Blocking. Office of the National community hospital ED. The American Jour- Coordinator for Health Information Technol- nal of Emergency Medicine, Elselvier, June tional effort to block health infor- ogy. April 2015. https://www.healthit.gov/sites/ 2013. https://www.sciencedirect.com/sci- mation exchange by a vendor or default/files/reports/info_blocking_040915.pdf ence/article/pii/S0735675713004051 provider. Although some industry 12 Slabodkin, G. “ONC working on information 10 Casalino, L. P., et al. “US Physician Practices blocking rule mandated by Cures Act.” Spend More Than $15.4 Billion Annually To experts say interoperability issues Health Data Management, Nov. 10, 2017. Report Quality Measures.” Health Affairs, vol. are only technical problems, https://www.healthdatamanagement.com/ 35, no. 3, Jan. 2016, pp. 401–406., doi:10.1377/ news/onc-working-on-information- hlthaff.2015.1258. research by the Office for the blocking-rule-mandated-by-cures-act

6 “Interoperability has been a big and technical standards in TEFCA issue,” she says. “Do you have that are necessary to advance access to the data you need, the unified on-ramp to interoper- “Health IT and technological across the care continuum, for the ability envisioned by the Cures Act. advances are tools case various clinicians that provide care to your patients? Whether it’s a Affirming patients’ right managers can use to better hospital admission or discharge, to health information inform and better serve seeing a specialist or having tests done—we need this. We’ve been Patient access to health informa- clients. For all of us, the talking about it for a long time, and tion is also affirmed in the Cures Cures Act—we hope—will we aren’t there yet.” Act. Although previous laws required providers (that used enable new treatments, new Barriers to interoperability include certified EHRs) to make individual ways to leverage data, and the lack of a business case for records available to patients, health systems and EHR vendors. providers have not always made the promise of new cures.” There is a cost associated with it simple for patients to access interoperability, and as the number their own data. — MARYBETH KURLAND, CAE CEO, COMMISSION FOR CASE of health data sources expand, so MANAGER CERTIFICATION does the complexity of creating “The law didn’t need to change, interfaces that work across but this was a symbolic act on all systems. the part of Congress—that the Department of Health and Human managers to help clients meet Federal regulators have also hit Services should encourage part- their health care goals.” road blocks when it comes to nerships with the goal of offering agreement on and adoption of patients access to their health Advances in technology—data common standards for health information, and educate provid- interoperability, new treatments information exchange. Those stan- ers on ways to provide that and devices—support the core dards—like patient identifiers and access,” Marchibroda says. work of case managers, says uniformity of how data is arranged (To read more about this topic, CCMC’s Kurland. “Technology —are critical for information to see CCMC’s March 2016 issue grabs our attention, and the idea seamlessly move from one record brief, P is for Portability.) of precision medicine initiatives to to the next. It’s a tricky balance personalize treatments is truly to ensure patient information is “I think these health IT provisions exciting,” she says. “Health IT and secure while still allowing vendors will have the most impact on case technological advances are tools to innovate and improve how managers’ day-to-day work,” she case managers can use to better EHRs function. says. “They will help to alleviate inform and better serve clients. For the frustration of not knowing a all of us, the Cures Act—we hope— One bright spot is broad support client’s previous diagnoses, or will enable new treatments, new in the EHR industry for the ONC’s what medical products or pre- ways to leverage data, and the draft Trusted Exchange Framework scriptions they’re using, what aller- promise of new cures.” n and Common Agreement gies they have, or what lab and (TEFCA)13. Introduced in January radiology tests they’ve done. 2018, the ONC will review public Interoperability supports care comments and move quickly to coordination, which is such a key finalize the policies, procedures component of the case manager’s work. Implementation of these 13 For more on TEFCA,see https://beta.healthit. measures should provide more gov/topic/interoperability/trusted-exchange- framework-and-common-agreement. supportive data for case

7 About the Experts

Janet Marchibroda Director, Health Innovation MaryBeth Kurland, CAE Executive Director, CEO, Commission for CEO Council on Health Case Manager Certification and Innovation Bipartisan Policy Center

JANET MARCHIBRODA is the director of the Bipartisan MARYBETH KURLAND leads and sets the Commission’s Policy Center’s Health Innovation Initiative and strategic mission and vision. She manages relation- executive director of its CEO Council on Health and ships with likeminded organizations and oversees Innovation. Her work focuses on advancing innovative business development as well as the Commission’s strategies to improve health and health care, effec- programs, products and services. She works directly tively using data and technology to improve the lives with the Board of Commissioners, building its corps of individuals and accelerating medical innovation. of volunteer and subject-matter experts who directly She also supports the Centers for Disease Control and support and evaluate certification and related Prevention’s efforts to improve immunization rates services. Prior to becoming CEO, Kurland served as and combat the Zika virus. the Commission’s chief operations officer, and was staff lead for the development and launch of the Marchibroda previously served as IBM’s chief health Commission’s signature conference, the CCMC care officer for global business services and as chief New World Symposium®. operating officer for the National Committee for Quality Assurance. She served as chief executive Kurland brings extensive experience to her role, officer of the eHealth Initiative, at the same time having served as executive director of organizations leading Connecting for Health, an initiative supported including the Association of Medical Media, Office by the Markle Foundation and Robert Wood Johnson Business Center Association International and the Foundation. She previously led stakeholder engage- League of Professional System Administrators. She ment activities for the National Coordinator for Health holds a bachelor’s degree from the University of Information Technology within the Department of Delaware and is a member of the Institute for Health and Human Services. Marchibroda holds a Credentialing Excellence, the American Society master’s degree in business administration with a of Association Executives and the Mid-Atlantic concentration in organization development, from Society of Association Executives. In 2011, Kurland George Washington University. was recognized as Association TRENDS Young & Aspiring Association Professional.

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